Status:
COMPLETED
Study to Evaluate the Leish-111F + MPL-SE Vaccine in the Treatment of Cutaneous Leishmaniasis
Lead Sponsor:
Access to Advanced Health Institute (AAHI)
Collaborating Sponsors:
Bill and Melinda Gates Foundation
Conditions:
Leishmaniasis, Cutaneous
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
Brief Summary
This study will evaluate the safety of the Leish-111f + MPL-SE vaccine in adult patients with cutaneous leishmaniasis.
Detailed Description
Cutaneous leishmaniasis is a disfiguring infection that can progress to mucosal leishmaniasis, a more serious and possibly fatal form of leishmania infection. All available medical therapies require w...
Eligibility Criteria
Inclusion
- Confirmed diagnosis of cutaneous leishmaniasis defined as positive identification of parasite from lesion biopsy
- Normal lab values and electrocardiogram (ECG)
- Negative for HIV, hepatitis B and C, and Chagas disease
Exclusion
- Nine or more active cutaneous lesions
- Lesion diameter \>60mm
- Previous exposure to Leishmania vaccines or to MPL-SE
- Pregnant or breastfeeding female
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
End Date :
August 1 2006
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT00111553
Start Date
October 1 2004
End Date
August 1 2006
Last Update
February 15 2007
Active Locations (2)
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1
Universidade Federal de Minas Gerais
Belo Horizonte, Minas Gerais, Brazil, 31270-901
2
Ambulatório de Leishmanioses da Secretaria Municipal da Saude de Januária
Januária, Minas Gerais, Brazil, 39480-000